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In-process specs & reconciliation (21 CFR 111.110)

TL;DR

21 CFR 111.110 requires written in-process specifications for any point/step/stage of manufacturing where control is needed to ensure the quality of the supplement, with material reconciliation at each. The typical points: blend uniformity, capsule/tablet weight, hardness, fri...

21 CFR 111.110 requires written in-process specifications for any point/step/stage of manufacturing where control is needed to ensure the quality of the supplement, with material reconciliation at each. The typical points: blend uniformity, capsule/tablet weight, hardness, friability, disintegration, in-process moisture, fill weight. The reconciliation (theoretical vs actual yield, with investigation of any excursion outside the action limit) is checked at every FDA inspection.

Regulatory anchors
  • 21 CFR 111.110
How V5 handles it
QMS — quality engineered into every action, not bolted on.
Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.
Document control with hard kiosk-level training enforcement.
Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.
Related terms
MMR elements per 21 CFR 111.205BPR elements per 21 CFR 111.255
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